Do Software Upgrades Fall Under the Definition of Recall per SOR/98-202?

[blah01]

We produce a standalone software considered as a Class I medical device under this MDR. During our last HC inspection, the inspector told us that all field software upgrades should be considered a ‘recall’ based on point ‘b’ of the definition which reads as follows:
“(b) may fail to conform to any claim made by the manufacturer or importer relating to its effectiveness, benefits, performance characteristics or safety;”

Like any software product, we occasionally have field upgrades to improve functionality or slight anomalies detected over time. However, being a Class I device, these do not pose any risks to users. We therefore find it to be an extreme interpretation that any field upgrades have to be reported per the Recall requirements (sections 63-65).

I’m hoping to get feedback regarding interpretation of the Recall definition and requirements in the context of software upgrades.

Note that I browsed through several threads in the ‘Canada Medical Device Regulations’ forum already and couldn’t find anything about Recall. If there is such a thread I’d appreciate a link to it.

Thanks in advance.

[shimonv]

Hi blah01,
Let's zoom out for a second. This is what the HC guidance says:

================\\
"Recall" is defined in the MDR as follows:

A "recall" in respect of a medical device that has been sold, means any action taken by the manufacturer, importer or distributor of the device to recall or correct the device, or to notify its owners and users of its defectiveness or potential defectiveness, after becoming aware that the device:

(a) may be hazardous to health
(b) may fail to conform to any claim made by the manufacturer or importer relating to its effectiveness, benefits, performance characteristics or safety
(c) may not meet the requirements of the Food and Drugs Act or these regulations

A recall may include:

- removing a medical device from the market
- instructing customers to stop using a medical device and destroying remaining units in stock
- doing an on-site correction of a medical device
- advising users of a device about a problem or potential problem
- supplying different labelling (which may include updates to instructions or manuals)"
=================\\.

The regulator doesn't want to be bothered by every little change that you do. If this was the case then they wouldn't be able to cope with the amount of recall notifications.

The examples in the guidance document shows that that recall is about changes with significant impact on safety or effectiveness.

The inspector was latching onto point "b". Please not that the word "claim". It's about the major features of the device that fulfill its intended use. It's not about small enhancements or minor fixes.
Of course, there is some grey area between enhancement, a fix with no impact on safety and effectiveness and a fix which comes in response to safety or effectiveness issue.
The way you justify your decision is through your documentation and risk analysis.

-Shimon

[mihzago]

I concur with Shimonv's suggestion.
Maybe what the inspector was saying is that you should consider recall requirements whenever you make software changes.
What I do to address this, when I document the change, I include a brief paragraph with an assessment explaining why this change is not considered recall.

[Access2hc]

I concur with shimonv's opinions. just to focus a bit more on the justification of each bug fix or enhancement.

in the unlikely event that the software fails to meet (any part of) its intended use, and has an impact on safety/performance, perhaps a consultation with the regulator is required.

most events are due to nuisance software events, or errors/inefficiencies of the workflow that does not impact the intended function of the software, or that the user wants to give feedback about the usability of the software which again does not impact on the intended purpose or the safety/performance of the software. these are not reportable

hope it helps

Cheers,
Ee Bin
@Access2HC

[blah01]

Thanks everyone for the useful feedback. This really helped clarify things.

All I've decided to do is make an amendment to our change review record, which already has a section to identify if a Recall is applicable or not, to now also capture the rationale why a Recall is not applicable. I am thinking of using the following as standard text going forward:
"Fixes in this release have no correlation to product claims, intended use or safety."

I'd appreciate feedback if you think I should tweak this statement, otherwise thanks again for the help.